Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sentreheart, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
388 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | 2015-11-25 | 30 | 0 |
| K142241 | LARIAT sulture Delivery Device | Sentreheart, Inc. | 2014-09-12 | 30 | 0 |
| K090385 | LARIAT II SUTURE DELIVERY DEVICE | Sentreheart, Inc. | 2009-05-06 | 78 | 0 |
| K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | Sentreheart, Inc. | 2008-08-11 | 182 | 1 |
| K070126 | OCCLUSION BALLOON CATHETER | Sentreheart, Inc. | 2008-02-08 | 388 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda